Senior Technician, Operations USA - North Carolina - Durham (Old Oxford)

Job Description

Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a “Safety First, Quality Always” mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.

We are seeking a Growth and Improvement minded Senior Manufacturing Pharmaceutical Operations Technician that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Senior Manufacturing Pharmaceutical Operations Technician is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of pharmaceutical drug substance and product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse and will be a part of the Drug Product Team, focusing on product filling and lyophilization.

As the Team finishes design and construction of the facility, the Lead Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Key Functions

Project Support

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of facility

• Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations

• Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel

• Actively participate in team meetings HAZOPS, waste walk throughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives

Operational Expertise

• Competent implementation and ownership to meet production targets for area within responsibility including:

  • Attending and escalation of concerns or needs at daily huddles and as needed

  • Cleaning, setup, operation and troubleshooting of equipment and facilities

  • Maintenance and transportation of consumable and material inventories

  • Maintenance of excellent record keeping and housekeeping

• Drives culture of continuous improvement. Implements and raises ideas to increase success of group

• Participates and completes activities to support technical and OPEX functions such as Kaizen events, ad-hoc sampling, or protocol implementation

• Maintains detailed knowledge of equipment and processes

• Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel

Shift

2nd Shift

• 1st Shift initially Monday to Friday then transitioning to 2nd Shift when operations starts, expected in 2023

Education

• Required | High School diploma/GED or higher

• Preferred | Associate degree in science or related field

Experience | Skills | Knowledge

Required

• (2) years GMP manufacturing/processing experience

• Principled verbal and written communications

• Successfully pass and maintain aseptic gowning qualifications | Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves, and boots

• Computer literacy (internet browsers, e-mail, spreadsheets, word processing)

• Successful completion of TB titer and Chest X-ray

Preferred

• Bioworks Certificate (working in an FDA or similar regulated industry)

• Applicable mechanical and project management experience

• Experience with automated systems (MES, SAP, DeltaV, or similar)

• Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)

• Demonstrated ability to work both independently and as a part of a team

Significantly Advantageous Experience

• Aseptic filling operations

• Grade A isolator containment systems

• Lyophilization

• Visual inspection of product in glass vials including manual & automated techniques

• Experience with autoclaves, washers, and dry heat ovens

Work ​Physical Requirements

• Able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R230412